MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. UNK_ENDOPATH* HAND HELD DEVICE 3MM-5MM-10MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	UNK_ENDOPATH* HAND HELD DEVICE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients undergoing unknown procedure.Evaluation of outcomes of endopath endoscopic hand instruments.Presence of an icd-9/10-cm primary or secondary diagnosis code for accidental puncture or laceration during the index admission.Icd-9/10-cm primary or secondary diagnosis code.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/9/2024.D4: batch # unk.This report is related to a clinical evaluation report from a related research activity database; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 19072267
• Report Number: 3005075853-2024-02742
• Device Sequence Number: 6853313
• Product Code: MDM
• UDI-Device Identifier: 10705036000761
• UDI-Public: 10705036000761
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_ENDOPATH* HAND HELD DEVICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown