MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPOUCH RETRIEVER SPEC BAG; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number POUCH

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unknown.Maude report # mw5077073.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: how was the procedure completed? after the pouch tore, the doctor irrigated the cavity site, removed all identified stones and content.Was there any patient consequence? no consequence.

Event Description

During an unknown procedure; ¿upon removing the gallbladder that was contained in an endo-pouch through a laparoscopic abdominal port site, the end-pouch tore.Gallbladder contents spilled into the abdominal cavity.The surgeon verified that to assist in pulling the pouch out of the port, he utilized surgical clamps.Surgeon confirmed the pouch did not rip at the site of the clamps.According to the nurse manager and surgeon, all parts of the endo-pouch were accounted for.¿ no additional information was provided.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Batch # r92h6c, r92j8m, r92e40.Device analysis: the analysis results confirmed that only the bag and suture of the pouch device were returned, the bag damaged and the suture cut.In addition, the tyvek was returned along with the instrument.Upon evaluation, the bag was noted to be torn at the bottom end (not at the seams).The torn portion was noted stretched.Following precautions should be taken: ( do not attempt to remove the bag with specimen through the trocar as this may lead to bag rupture and spillage of contents.) (care should be taken to avoid contact of the bag with sharp instruments, cutting devices, electrocautery and laser or other instruments.) (excessive forces should be avoided during bag extraction.) the reported complaint was confirmed.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: ENDOPOUCH RETRIEVER SPEC BAG
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7586821
• MDR Text Key: 111091014
• Report Number: 3005075853-2018-10474
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036012983
• UDI-Public: 20705036012983
• Combination Product (y/n): N
• PMA/PMN Number: K011501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: POUCH
• Device Lot Number: R40756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1