MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GRASP; FORCEPS, OBSTETRICAL

Model Number 173030

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Customer states: when surgeon grasped cholecyst first the first time a part of jaws broke and fell into the abdominal cavity.The broken parts were immediately retrieved.Procedure: laparoscopic cholecystectomy udi number is not available.The event occurred in use for patient.The procedure was completed with another device.The surgical time was not extended.The status of the patient: no problem.Additional tissue resection is not required.There was no tissue damage.The incision site was not extended.The product did not lock on tissue and was removed from the tissue without damaging it.No bleeding occurred.The patient gender is not available.The patient age is not available.The patient weight is not available.The device was not reprocessed/re-sterilized prior to use.Additional information received via email: can you confirm that product is available and will be returned for evaluation.Yes.How was the piece retrieved from the patient's cavity? the piece was retrieved with forceps.What is the product id and lot number for the reload used with this stapler? if the customer cannot supply the product id or lot number, was the reload a universal roticulator sulu, a straight sulu, or a tri-staple reload?n/a.Could you please provide the udi# for the reload used in the procedure? no information is available.Was any reinforcement material used in conjunction with the stapling device?a.

Manufacturer Narrative

Evaluation post market vigilance (pmv) led an evaluation of one device.The event report alleges the product was used in a surgical procedure.One of the jaws was disengaged from the instrument.The disengaged jaw was received taped to the handle of the instrument.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur as a result of the instrument being handled roughly during use, grasping hard material and twisting the device.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.No relationship between the device and the reported incident was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to customer: when surgeon grasped cholecyst first time a part of jaws broke and fell into the abdominal cavity.The broken parts were immediately retrieved with forceps.Procedure: laparoscopic cholecystectomy udi number is not available.The event occurred in use for patient.The procedure was completed with another device.The surgical time was not extended.The status of the patient: no problem.Additional tissue resection is not required.There was no tissue damage.The incision site was not extended.The product did not lock on tissue and was removed from the tissue without damaging it.No bleeding occurred.The patient gender is not available.The patient age is not available.The patient weight is not available.The device was not reprocessed/re-sterilized prior to use.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GRASP
• Type of Device: FORCEPS, OBSTETRICAL
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6530656
• MDR Text Key: 74089538
• Report Number: 2647580-2017-05353
• Device Sequence Number: 1
• Product Code: HDA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K903205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173030
• Device Catalogue Number: 173030
• Device Lot Number: P6F0201PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1