MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; CLIP, IMPLANTABLE

Model Number CA500

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Type of procedure performed: laparoscopic cholecystectomy.The surgeon has used our clip applier several times, however, during this case none of the clips were staying in place and clipping properly.He was closing the handle plastic to plastic but the sides of the clip were not holding onto the cystic duct and cystic artery.On some clips he even tried several times to press hard on the handle and it ended up causing some scissoring at the clip.He had to use all the 20 clips without being able to clip the targeted structures, so he sutured them instead.Patient status: no patient injury, surgeon used sutures as an alternative.Type of intervention: procedure completed with alternative method.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and applied medical was unable to confirm or replicate the complainant¿s experience.In the absence of the event unit, applied medical is unable to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the nature of the failure and the exact root cause of the event.The event was determined to be reportable based on the original description of the event.However, upon receipt of additional information, applied medical determined that the event was not reportable as it is unlikely to cause or contribute to death or serious deterioration in the state of health.

Event Description

Type of procedure performed: laparoscopic cholecystectomy.The surgeon has used our clip applier several times, however, during this case none of the clips were staying in place and clipping properly.He was closing the handle plastic to plastic but the sides of the clip were not holding onto the cystic duct and cystic artery.On some clips he even tried several times to press hard on the handle and it ended up causing some scissoring at the clip.He had to use all the 20 clips without being able to clip the targeted structures, so he sutured them instead.Additional information received via email from applied medical lebanon (b)(6) 2021: there are no remaining clips but, the surgeon might be able to send us the recorded case (i will send it to you as soon as i get it).The surgeon said that there was no scissoring on vessels.No the surgeon did not torque the jaws on any structure.The surgeon did skeletonize the structure before the application of the clip ( he was surprised by what was going on since it wasn¿t his first time.He always uses our clip applier).The clip was fully loaded into the jaws.The surgeon mentioned that the tip was closing but the apex did not, it kept being loose and not holding onto the structure.The clips were falling off.Additional information received via email from applied medical lebanon 28mar21: the case has not been recorded.A video is not available.Patient status: no patient injury, surgeon used sutures as an alternative type of intervention: procedure completed with alternative method.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.The returned unit was visually inspected and no non-conformances were observed.Testing was unable to be performed as the returned unit did not have any clips remaining and was locked out.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause based on the evaluation of the event unit that was returned and the description of the event.The event was reported based on the original description of the event.However, upon receipt of additional information, applied medical determined that the event was not reportable as it is unlikely to cause or contribute to death or serious injury.

Event Description

Type of procedure performed: laparoscopic cholecystectomy.The surgeon has used our clip applier several times, however, during this case none of the clips were staying in place and clipping properly.He was closing the handle plastic to plastic but the sides of the clip were not holding onto the cystic duct and cystic artery.On some clips he even tried several times to press hard on the handle and it ended up causing some scissoring at the clip.He had to use all the 20 clips without being able to clip the targeted structures, so he sutured them instead.Additional information received via email from applied medical lebanon 18mar21: there are no remaining clips but, the surgeon might be able to send us the recorded case (i will send it to you as soon as i get it).The surgeon said that there was no scissoring on vessels.No the surgeon did not torque the jaws on any structure.The surgeon did skeletonize the structure before the application of the clip (he was surprised by what was going on since it wasn¿t his first time.He always uses our clip applier).The clip was fully loaded into the jaws.The surgeon mentioned that the tip was closing but the apex did not, it kept being loose and not holding onto the structure.The clips were falling off.Additional information received via email from applied medical lebanon 28mar21: the case has not been recorded.A video is not available.Patient status: no patient injury, surgeon used sutures as an alternative type of intervention: procedure completed with alternative method.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11498464
• MDR Text Key: 243365123
• Report Number: 2027111-2021-00388
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)230121(30)01(10)1378862
• Combination Product (y/n): N
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1378862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 02/22/2021; 02/22/2021
• Supplement Dates FDA Received: 05/28/2021; 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1